Engineering

Carcinoma

Urology

Classical mechanics

Urothelial carcinoma

Mechanical engineering

Metastatic Urothelial Carcinoma

Physics

Throwing

Javelin

Pembrolizumab

Internal medicine

Oncology

Medicine

Immunotherapy

Bladder cancer

Cancer

Avelumab

The Journal of Urology

You have accessJournal of UrologyBladder Cancer: Invasive II (MP41)1 Sep 2021MP41-13 AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA: ANALYSIS OF CLINICAL AND GENOMIC SUBGROUPS FROM THE JAVELIN BLADDER 100 TRIAL Thomas Powles, Daniel P Petrylak, Se Hoon Park, Srikala S Sridhar, Claudia Caserta, Antoine Thiery-Vuillemin, Hyo Jin Lee, Joaquim Bellmunt, Yoshiaki Yamamoto, Jeanny B Aragon-Ching, Bo Huang, Keith Ching, Craig Davis, Alessandra di Pietro, Yohann Loriot, and Petros Grivas Thomas PowlesThomas Powles More articles by this author , Daniel P PetrylakDaniel P Petrylak More articles by this author , Se Hoon ParkSe Hoon Park More articles by this author , Srikala S SridharSrikala S Sridhar More articles by this author , Claudia CasertaClaudia Caserta More articles by this author , Antoine Thiery-VuilleminAntoine Thiery-Vuillemin More articles by this author , Hyo Jin LeeHyo Jin Lee More articles by this author , Joaquim BellmuntJoaquim Bellmunt More articles by this author , Yoshiaki YamamotoYoshiaki Yamamoto More articles by this author , Jeanny B Aragon-ChingJeanny B Aragon-Ching More articles by this author , Bo HuangBo Huang More articles by this author , Keith ChingKeith Ching More articles by this author , Craig DavisCraig Davis More articles by this author , Alessandra di PietroAlessandra di Pietro More articles by this author , Yohann LoriotYohann Loriot More articles by this author , and Petros GrivasPetros Grivas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002062.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the phase 3 JAVELIN Bladder 100 trial, avelumab first-line (1L) maintenance+best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in patients (pts) with advanced urothelial carcinoma (UC) that had not progressed on 1L platinum-based chemotherapy (HR, 0.69 [95% CI: 0.56, 0.86; 1-sided p=0.0005]). We report post hoc analyses in previously unreported clinical and genomic subgroups. METHODS: In JAVELIN Bladder 100 (NCT02603432), eligible pts had unresectable locally advanced or metastatic UC without progression after 4-6 cycles of 1L gemcitabine+cisplatin or carboplatin, and were randomized to receive avelumab+BSC (n=350) or BSC alone (n=350). The primary endpoint was OS, in all randomized pts and pts with PD-L1+ tumors (Ventana SP263 assay). In this exploratory analysis, we analyzed OS in disease stage and site subgroups, in pts with PD-L1+ tumors who received 1L gemcitabine+carboplatin, and in genomic subtypes (RNAseq whole-transcriptome profiling of tumor tissue) defined using data from The Cancer Genome Atlas (TCGA 2017). Interaction tests were not performed. RESULTS: Prolonged OS was observed in the avelumab+BSC arm vs the BSC alone arm in pts with upper or lower tract tumors, metastatic or locally advanced (LA) and unresectable disease (prior to chemotherapy), and lymph node-only disease post-chemotherapy (Table). OS was also prolonged with avelumab+BSC in pts in PD-L1+ tumors who had received 1L gemcitabine+carboplatin, consistent with findings in the overall population. In genomic subtypes, the OS benefit for avelumab+BSC was apparent across TCGA subtypes except luminal. CONCLUSIONS: An OS benefit was seen for avelumab 1L maintenance+BSC vs BSC alone across subgroups of interest. Results are consistent with previously reported findings, further supporting avelumab 1L maintenance as a standard of care for pts with advanced UC that has not progressed with 1L platinum-containing chemotherapy. Source of Funding: Funded by Pfizer as part of an alliance between Merck KGaA, Darmstadt, Germany and Pfizer © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e765-e766 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Thomas Powles More articles by this author Daniel P Petrylak More articles by this author Se Hoon Park More articles by this author Srikala S Sridhar More articles by this author Claudia Caserta More articles by this author Antoine Thiery-Vuillemin More articles by this author Hyo Jin Lee More articles by this author Joaquim Bellmunt More articles by this author Yoshiaki Yamamoto More articles by this author Jeanny B Aragon-Ching More articles by this author Bo Huang More articles by this author Keith Ching More articles by this author Craig Davis More articles by this author Alessandra di Pietro More articles by this author Yohann Loriot More articles by this author Petros Grivas More articles by this author Expand All Advertisement PDF downloadLoading ...

MP41-13 AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA: ANALYSIS OF CLINICAL AND GENOMIC SUBGROUPS FROM THE JAVELIN BLADDER 100 TRIAL